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Helping a Mid-Sized Pharma Company Get Ahead of the Curve on Compliance and Operations

By February 24, 2016March 16th, 2021Aggregation, Customers, DSCSA, Serialization

Understanding Challenges

“The biggest challenge with the act is its complexity. And for a company of our size the question was – where do we start?” That’s how Joseph Barna, Chief Financial Officer at Kowa Pharmaceuticals, summed up the organization’s feelings about the Drug Supply Chain Security Act (DSCSA) and serialization in 2015.

Shortly after I met with the executives from Kowa, LSPediA was retained to perform DSCSA strategic planning work. Our first step was to find out through a gap analysis exactly where the company stood from regulatory and operational readiness points of view. Based on those findings, our small-scale project quickly grew into a long-term relationship. Our partnership has not only put Kowa on-track to meet DSCSA compliance requirements, but also empowered employees with DSCSA and operational knowledge, and laid the groundwork for future growth through improved operational processes.

Identifying Opportunities

One of our value propositions, and something Kowa found so helpful, is our ability to not only help clients where they know they need help, but to also reveal “unknown unknowns” – improvements to processes and systems that they hadn’t even considered.

The gap analysis revealed that the company could benefit from a number of changes – changes that would help it meet short-term and long-term DSCSA requirements, but that would also eliminate inefficiencies that were hurting the company’s bottom line. Based on our findings, we established a number of goals:

  • Transition the company from paper-based warehouse processes to a fully automated warehouse management system
  • Select and implement a new EDI system that is DSCSA proven and tailored to the pharmaceutical industry
  • Establish a single enterprise resource planning (ERP) system as the system of record and eliminate a redundant system
  • Move the company away from underperforming technology vendors who failed to meet timely deliverables
  • Identify new technology architecture that would reduce slowdowns and eliminate other inefficiencies throughout the enterprise
  • Create and launch a detailed, organization-wide DSCSA roadmap that would ensure on-time compliance

And so, working alongside Kowa team members, we got to work: implementing the DSCSA strategy and Serialization Toolkit; building out the EDI, warehouse, and EPCIS technology infrastructure; managing CMOs; and reviewing and revising all standard operating procedures (SOPs).

Delivering Business Benefits

I recently spoke with Kenneth Riester, Vice President of Trade and Business Development at Kowa, who summed up his feelings about our partnership this way: “Our team has come together. We were probably moving too slow for a mid-sized pharma – we are now ahead of the curve, and we have plans to take it even further.”

As a result of our partnership, Kowa has seen a number of business benefits, including:

  • Organization-wide alignment on serialization
  • Improved management of Contract Manufacturing Organizations (CMOs)

And I’m happy to say that the changes we implemented will continue to bring improvements to the company for some time as some additional projects go live later this year, such as enhanced EDI and warehouse processes.

What Can LSPediA Help Your Business Achieve?  

We have a growing list of clients that are seeing real-world, bottom-line benefits around compliance, ERP, serialization, technology enhancements, and other areas. Watch some of our customer testimonials to see for yourself. And, to learn how LSPediA can help you achieve the same results, contact me today.